Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

NFO 2021-01-22

NuFace Trinity Plus Device

Applicant Carol Cole Company Dba Nuface

K-Number K201782

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QGT 2021-01-22

Nerivio, FGD000075-4.7

Applicant Theranica Bioelectronics , Ltd.

K-Number K203181

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JAA 2021-01-22

Platinum dRF Imaging System

Applicant Apelem-Dms Group

K-Number K203010

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HSB 2021-01-22

Flex-ThreadTM Distal Fibula Intramedullary Nail System

Applicant Conventus Orthopaedics, LLC

K-Number K202858

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GEX 2021-01-22

MIIN

Applicant Medico USA, Inc.

K-Number K193266

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GEI 2021-01-22

VirtueRF

Applicant ShenB Co., Ltd.

K-Number K202415

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GEI 2021-01-22

ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K201696

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HAW 2021-01-22

ClearPoint Array System

Applicant ClearPoint Neuro, Inc.

K-Number K202575

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OUR 2021-01-22

Advanced Research Medical Trident SI Screw System

Applicant Advanced Research Medical, LLC

K-Number K203373

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FLL 2021-01-22

Non-Contact Forehead Thermometer (UT30H)

Applicant Uni-Trend Technology (China) Co., Ltd.

K-Number K203656

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GEI 2021-01-22

ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length

Applicant Ethicon Endo-Surgery, LLC

K-Number K201066

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NHI 2021-01-22

SPRINT PNS System

Applicant Spr Therapeutics, Inc.

K-Number K202660

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